Summary
Remote (US); Boston, MA area preferred. Reports to Assistant Director, Compliance Operations, Systems & Process Lead.
Responsibilities
- Provide daily Healthcare Compliance Operations support/triage (compliance mailbox, routing, tracking, resolution).
- Support HCP engagement lifecycle (needs assessments, due diligence, FMV tiering, contracting, payment documentation).
- Administer compliance systems (user support, configuration, testing, troubleshooting, issue resolution).
- Support transparency reporting operations (data collection/processing, reconciliations, validation/remediation, submission readiness for U.S. federal/state and ex-U.S. requirements).
- Manage operational data quality; monitor trends; strengthen process controls.
- Create/maintain SOPs, business rules, process maps, work instructions, FAQs, job aids, training materials; deliver training/onboarding.
- Coordinate UAT, implementations/upgrades/enhancements, and change management.
- Track KPIs/metrics/dashboards; recommend corrective actions and process improvements.
- Build operational reports/presentations; identify automation/AI-enabled tools.
- Support audit readiness, inspections, internal monitoring, and regulatory inquiries.
- Support broader Compliance Operations priorities as needed.
Requirements
- Bachelorβs degree required.
- Manager: 2+ years related healthcare compliance operations (pharma/biotech/medical device) with Bachelorβs.
- Senior Manager: 5+ years (or 3+ years with an advanced degree).
- Direct experience: HCP engagement, transparency reporting, compliance systems administration.
- Knowledge of Anti-Kickback Statute, FCPA, PhRMA Code, OIG guidance, PDMA.
- Experience with compliance technologies/digital workflow solutions (incl. AI-enabled tools).
- Strong Excel; Power BI/Tableau or similar.
- Integrity/protection of confidential information; occasional domestic travel up to 20%.